Æterna Zentaris' Anti-Cancer Compound, Perifosine (KRX-0401), Receives FDA Fast Track Designation for the Treatment of Relapsed/Refractory Multiple Myeloma
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
"We are very pleased with the FDA's Fast Track designation and we look forward to the emergence of the data from the forthcoming Phase 3 clinical trial in multiple myeloma to be conducted by our partner Keryx, which we hope will establish perifosine as a novel treatment of this serious condition", stated Juergen Engel, Ph.D., President and CEO at Æterna Zentaris. "We further believe that this North American clinical development program will also be very useful to support the development and registration of perifosine for the benefit of patients in the rest of the world."
A Phase 3 trial investigating perifosine in combination with bortezomib (VELCADE(R)) and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma is expected to commence by year-end under a Special Protocol Assessment (SPA) with the FDA. In addition, in September, perifosine had received Orphan-Drug designation in the
About Perifosine (KRX-0401)
Perifosine is a novel oral anticancer agent that modulates several key signal transduction pathways, including Akt, MAPK, and JNK that have been shown to be critical for the survival of cancer cells. Perifosine has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. Perifosine is currently in Phase 2 clinical development for multiple tumor types, with a Phase 3 in multiple myeloma, under Special Protocol Assessment (SPA), pending commencement by year-end. Perifosine has also received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma.
About Multiple Myeloma
Multiple myeloma, a cancer of the plasma cell, is an incurable but treatable disease. Multiple myeloma is the second most-common hematologic cancer, representing 1% of all cancer diagnoses and 2% of all cancer deaths. According to the American Cancer Society, in 2009 there will be an estimated 20,580 new cases of multiple myeloma and an estimated 10,500 deaths from multiple myeloma in the
About Æterna Zentaris Inc.
Æterna Zentaris Inc. is a global biopharmaceutical company focused on endocrine therapy and oncology, with proven expertise in drug discovery, development and commercialization. News releases and additional information are available at www.aezsinc.com.
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